Hospital and Other Healthcare Facilities Council Progress Report December 2015 Judy Chong, RPh, BScPhm Manager, Hospital and Other Healthcare Facilities
Agenda Background Drug Preparation Premises (DPPs) OCP Hospital Oversight Next Steps Discussion
Under-dosing of chemotherapy medication March 2013 Incident discovered April 2013 Thiessen named to lead independent study August 2013 Thiessen Report and recommendations released to the public and accepted by government September 2013 Implementation Task Force established
Thiessen Recommendations #6 Define best practices and contemporary standards for non-sterile and sterile product preparation #7 Stipulate specialized electronic material records and label requirements for non-sterile and sterile product preparation #8 Inspection of Drug Preparation Premises (DPPs) where pharmacists and pharmacy technicians work #9 Specified credentials for personnel engaged in sterile and non-sterile compounding #12 License all pharmacies operating within Ontario s clinics or hospitals
OCP Quality Assurance Ontario College of Pharmacists People Place Pharmacists Pharmacy Technicians Community Pharmacies Drug Preparation Premises Hospitals & Other Facilities
Drug Preparation Premises May 2013 authority provided through changes to the regulatory framework May to July 2013 Inspection Criteria developed through collaborative process DPPs identified and inspected August 2013 initial inspections complete; outcomes (pass) posted on public register August / September 2014 & 2015 annual inspections complete; outcomes (pass) 2016 review of inspection criteria
OCP Oversight of Hospitals Dec 2014 Bill 21 Safeguarding Healthcare Integrity Act 2014 passed by government June 2015 Enabling DPRA regulations, following public consultation, approved by council and submitted to government Baseline Assessments of Hospital currently underway target for accreditation January 2016
OCP Oversight of Hospitals Overriding Objectives: Assess pharmacy and practitioner adherence to operational and practice standards Prioritize focus based on patient and/or public risk Support and mentor facilities and individuals to develop necessary action plans and timelines to meet required standards Identify and share best practices amongst facilities and individuals continuous quality improvement (CQI)
OCP Oversight of Hospitals Principle-Based Approach 1. Collaborative In process development and inspection process 2. Flexible Adaptable to various practice sites and activities 3. Continuous Quality Improvement (CQI) Solid base already in place (system is not broken) Supportive and educational (not punitive) 4. Mandate of Public Interest Safe and effective delivery of pharmacy services
OCP Oversight of Hospitals Development of Inspection Criteria: Intent was to not duplicate but rather compliment and enhance what already exists Criteria Cross Reference
Hospital Baseline Assessments Early 2015 Baseline Assessments of Hospital pharmacies began Approximately 225 hospital sites in Ontario Current Status approximately 99% complete Anticipate all baseline assessments will have been completed by the end of 2015 13
Hospital Baseline Assessments Assessment Criteria - Overview: 3 categories of criteria legislation, emerging and organizational Each criteria evaluated against applicable criteria Meets (3) Partially Meets (2) Does not Meet (1) N/A or N/I Continuous quality improvement process with realistic action plans and timelines established Follow up visit and/or remediation as required
Hospital Baseline Assessments Assessment Criteria - Overview: A. Systems to Provide Safe, Effective and Appropriate Pharmacy Services B. Order Processing, Verification, Dispensing and Distribution C. Preparation, Packaging and Labelling of Medication D. Pharmaceutical Compounding E. Safe Medication Use Systems in Patient Care Areas F. Medication Therapy Management G. Documentation and Record Keeping H. Evaluation of Pharmacy Services
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Approximately 225 sites in Ontario 99% complete as of Dec 2015 17
Themes of Findings Operations (place): Policies and Procedures Traceability and Record Keeping Compounding (USP 795, 797 and 800) Practice (people): Professional Responsibilities Individual practitioner Intra-Professional and Inter-Professional Relationships Pharmacists and Pharmacy Technicians Pharmacy team with other healthcare professionals
Compounding Standards Identified need to develop Standards at a national level Accelerated work already begun by NAPRA Working group established Spring 2013 Objective to develop 3 Standards documents: Sterile Compounding Hazardous Sterile Compounding Non-Hazardous Non-Sterile Compounding 19
Compounding Standards Sterile Hazardous & Non-Hazardous Primary drivers USP 795, 797 and Quebec Compounding Standards Draft documents developed through consultative process: Initial circulation to stakeholders Summer 2014 Working Group revised documents and recirculated (to Regulatory Bodies) Early 2015 Final revisions made (with USP 797 expert) NAPRA approved document April 2015 20
Compounding Standards Next Steps / Timeline: Sterile Hazardous & Non-Hazardous Editing and formatting (including French translation) Non-hazardous to be made available by NAPRA end of 2015 Hazardous to be made available by NAPRA early 2016 Each Regulatory Body in Canada will then need to consider; adopting or adapting (similar process to National Standards of Practice) May include implementation dates 21
Compounding Standards Non-Sterile Primary drivers USP 795 and Quebec Compounding Standards NAPRA working group will develop through 2015 Consultation process through 2016 Final NAPRA approval anticipated before the end of 2016 Each Regulatory Body in Canada will then need to consider; adopting or adapting 22
Specified Credentials Compounding Standards Sterile: Hazardous and Non-Hazardous Compounding Competencies Required Knowledge and Skills Educational Outcomes Learning Objectives Curriculum Training Program(s)
System Gaps / Priority Setting Overriding Objectives of Oversight: Assess pharmacy and practitioner adherence to operational and practice standards Prioritize focus based on patient and/or public risk Support and mentor facilities and individuals to develop necessary action plans and timelines to meet required standards Identify and share best practices amongst facilities and individuals continuous quality improvement (CQI) 24
System Gaps / Priority Setting Themes of Findings: Understanding of requirements for a safe medication management system Integration of regulated pharmacy technicians and role of unregulated staff After hours support by tele pharmacy service for order entry verification Automated dispensing cabinets Traceability and auditability for high risk products (chemotherapy, methadone and patient specific compounds) 25
System Gaps / Priority Setting Action plans required to achieve compounding standards (facilities, people & processes, quality monitoring and cleaning) Action plans to increase security for narcotics and other medications Action plans to achieve standards for chemotherapy preparation Processes in place that consistently ensure therapeutic checks for all orders Storage of medications in syringes for both parenteral and oral usage 26
System Gaps / Priority Setting Themes of Recommendations: 1. Re-assess ability to safely and effectively provide specific services; explore alternative options such as centralizing, regionalizing and/or outsourcing 2. Continuous improvement plans should be prioritized based on areas of highest risk and include education to all relevant staff on enhancements to processes and procedures 3. Where gaps exist, develop policies and procedures to ensure accountability and consistency of services 27
System Gaps / Priority Setting Themes of Recommendations: 4. Identify opportunities to enhance professional responsibilities e.g. work to full scope 5. OCP recognizes the opportunity to bring best practices from the community to hospital practice 6. Review and conduct risk assessment of storing medications in syringes 28
Regulatory Framework - Update Proposed amendments to College By-laws Sept 2015 Council approved proposed amendments for 60-day public consultation Consultation ended Nov 20, 2015 Dec 2015 Council to consider approval of proposed amendments reflective of comments received through the consultation process Certificate of Accreditation Early 2016 29
Next Steps 2016 and beyond Review and revise baseline assessment criteria Finalize business processes for accreditation Develop schedule, including frequency, for ongoing assessments Incorporate individual practitioner assessment component 30
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Questions? 32